Featured Pharma Online Editorial

81. Dispelling 4 Common Myths Of Data Quality Governance 3/9/2023

    Achieving robust data quality governance doesn't need to be an unwieldy prospect. Here, we dispel the four common myths of data quality governance and share the three phases of a good data quality governance program.

82. Expanding Treatment Options With Oral Therapies For Immune-Mediated Inflammatory Diseases 2/24/2023

    One of the greatest advancements in treating immune-mediated inflammatory diseases (IMIDs) has been the advent of targeted biologic injectable therapies that target cytokines. However, oral cytokine inhibitors hold significant promise as next-generation options, offering the potential for improved safety, durability, and adherence.

83. The Discriminative Power Of Dissolution Methods In The US & Europe 2/22/2023

    The discriminatory power is a factor that may be game changing for dissolution testing of immediate release tablets in quality control or R&D. Let's examine the American perspectives (FDA and USP) and the European perspective (EMA).

84. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

85. 4 Focus Areas To Expand The Success Of Antibody-Drug Conjugates 2/9/2023

    Antibody-drug conjugates (ADCs) represent a significant advance in therapeutic engineering. They combine an antibody, a linker, and a payload designed into a single molecule for delivery to a specific target. Why do discontinuation rates remain high, and what are the novel strategies that we as drug developers can use to maximize success?

86. AI/ML In Drug Discovery & Development: Potential And Challenges 1/11/2023

    Selecting the wrong target molecule or focusing on the wrong area of investigation can cause major delays and waste valuable time and resources. Artificial intelligence (AI) and machine learning (ML) can help drug discovery researchers minimize these missteps in a few key ways.

87. FDA Adopts ICH Final Guidance On Bioanalytical Method Validation 1/11/2023

    The FDA has issued final guidance on the validation of biological assays, titled M10 Bioanalytical Method Validation and Study Sample Analysis. ICH approved the final guidance in May 2022, so this FDA adoption completes international acceptance of a unified approach. It extends to both full and partial validation for clinical and nonclinical studies.

88. The Need — And Opportunity — To Develop Broad-Spectrum Antivirals 1/3/2023

    One factor contributing to the lack of broad-spectrum antivirals is a lag in testing technology for viruses. This article discusses interferons (a group of signaling proteins secreted by cell types to coordinate the body’s natural antiviral responses) and other potential broad-spectrum antivirals, as well as the new testing initiatives being conducted.

89. 6 Drug Discovery Learnings From The Lab 10/5/2022

    With more than 25 years of experience, this author shares insights from the perspective of bench science that pertain to experimental design and data generation. These concepts apply not only to individual experiments but also more broadly.

90. Is Phage Therapy Ushering In A Post-Antibiotic Era? 10/3/2022

    Faced with the emergence of resistant bacteria, phage therapy, which uses bacterial viruses (bacteriophages) to treat bacterial infections, is emerging as one of the most credible alternatives to antibiotics.